Will Take Next-Generation Percutaneous Aortic Valve Replacement System to Commercial Viability.
Sadra Medical today announced it has raised $30 million in new investment capital. The round was led by Accuitive Medical Ventures, and includes existing investors Boston Scientific, Finistere, Firstmark Capital, Oakwood, ONSET Ventures, and SV Life Sciences.
Sadra is pioneering significant technical and clinical advancements to an aortic valve replacement procedure called “percutaneous aortic valve replacement” (PAVR), during which a valve prosthesis can be positioned in a patient’s heart by means of a catheter navigated through the patient’s arteries. PAVR allows a diseased aortic valve to be replaced with a minimally-invasive procedure, thus eliminating the trauma, long recovery times, and attendant risks of open-heart surgery. In spite of its minimally-invasive nature, however, PAVR is anything but routine.
“Because of the limitations of first generation systems – currently in use at specially trained hospitals in Europe and the U.S. – PAVR remains an exacting, challenging procedure requiring great technical skill, and the clinical outcomes vary greatly,” explained Charles E. Larsen, managing director and co-founder of Accuitive Medical Ventures. “Sadra expects to change this landscape significantly, providing physicians with the necessary technology to make PAVR a routine clinical procedure.”
Sadra’s breakthrough is a technology it calls the Lotus™ Valve System, the first fully repositionable prosthesis for percutaneous aortic valve replacement.
The system allows interventional cardiologists to easily navigate a technically-advanced prosthesis to the delivery site, and to precisely control its placement, without interruption to the patient’s normal circulatory processes. In addition to unique repositioning and self-centering features, the device has a proprietary delivery system that provides physicians with more control over the procedure, an early “leaflet” function during deployment that allows the valve to function immediately, and an ability to re-sheath and retrieve the prosthesis prior to final release. A unique adaptive seal minimizes leakage around the valve.
“Aortic valve replacement is a $2 billion market,” added Larsen. “By offering a solution that addresses the key needs doctors have identified as essential to make PAVR a standard therapy, and one which is less traumatic for the patient, the company has an excellent market opportunity.”
To date, Sadra has completed a European feasibility study, and is in the process of pursuing further clinical investigations. Early clinical trials have confirmed the value of the ease of accurate placement, repositionability, and retrievability of the valve. Moreover, the early functioning of the valve, allowing the patient’s hemodynamic stability to be maintained, and the valve’s adaptive sealing features, have been confirmed.
“We have had very successful European clinical experiences with our Lotus Valve System,” reported Ken Martin, Sadra Medical’s president and CEO. “We’ve confirmed through the physician and patient experience that we are firmly on the right track, and are designing even more improvements in functionality and user-friendliness as we move to bring the system to commercial viability.”
Source: Sadra Medical